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Bipartisan Bill to Lower Rx Drug Costs

[ Price : $8.95]

Reps. Eric Sorensen and Stephanie Bice introduce bipartisan legislation to allow FDA to deny so-called sham citizen petitions file...

Implantica Submits Final FDA Response for RefluxStop PMA

[ Price : $8.95]

Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agencys remaining questions tied to Module...

Valar Labs Wins Breakthrough Status for AI Bladder Cancer Test

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FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.

FDA Approves Guardant Healths Next-Generation Guardant360 Liquid CDx

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FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed ...

ImmunityBios Anktiva sBLA for Expanded Use Accepted by FDA

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FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln)...

CGMP Deviations at Hangzhou Yiqi Biotechnology

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FDA warns Chinas Hangzhou Yiqi Biotechnology Co. about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

TEMPO Digital Health Pilot FAQs

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FDA publishes frequently asked questions covering eligibility, statement of interest, and selection of participants for the TEMPO ...

Harbin Jixianglong Biotech API Deviations

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FDA warns Chinas Harbin Jixianglong Biotech about CGMP deviations and other violations in its manufacturing of active pharmaceutic...

Staff Up for Breakthrough Device Recall Oversight: Post

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A Stanford Law School Center for the Law and Biosciences fellow says policymakers should consider the growth in breakthrough medic...

Bayer Gets Priority Review for Stroke Drug

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FDA grants Bayer a priority review for its NDA for asundexian, an investigational oral Factor XIa inhibitor designed to reduce the...